New combo aims to tame CAR T-Cell side effects in leukemia
NCT ID NCT05993949
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tests whether adding pulses of the cancer drug dasatinib to standard CAR T-cell therapy (brexucabtagene autoleucel) is feasible and safe for adults with relapsed or refractory B-cell acute lymphoblastic leukemia. Eight participants receive dasatinib on a weekly 3-day schedule for up to 3 months after the CAR T-cell infusion. The goal is to see if this approach can reduce side effects without compromising the treatment's effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- brexucabtagene autoleucel (CAR T-cell therapy) plus dasatinib (a cancer drug)
- What this could lead to
- If successful, this combination could help control leukemia by reducing side effects of CAR T-cell therapy, making treatment safer and more tolerable.
- What could go wrong
- This is a very early, small phase 1 trial with only 8 participants, so results may not apply broadly. The drug dasatinib also has its own risks, including potential side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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8 people
The number who actually took part.
- Started
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Oct 2023
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Relapsed or refractory B-precursor ALL defined as one of the following: * Primary refractory disease (\>=5% blasts or persistent extramedullary disease following induction therapy) * First or later relapse of marrow or extramedullary disease * Persistence of MRD defined as detectable ALL by flow cytometry, PCR, or next-generation sequencing * Relapsed or refractory disease after allogeneic transplant provided individual is at least 100 days from transplant at time of enrollment * Patients with isolated, asymptomatic CNS relapse will be eligible * Age \>=18 years * Eastern cooperative oncology group (ECOG) performance status of 0-2 * Adequate renal, hepatic, pulmonary and cardiac function defined as: * Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 cc/min * Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN) * Total bilirubin ≤ 1.5 mg/dl, except in individuals with Gilbert's syndrome. * Cardiac ejection fraction ≥ 50%, no evidence of clinically significant pericardial effusion, and no clinically significant arrhythmias * Baseline oxygen saturation \> 92% on room air * QTc ≤ 500ms * In individuals previously treated with blinatumomab, CD19 tumor expression in bone marrow or peripheral blood by flow cytometry or extramedullary site by IHC or flow cytometry * Negative serum or urine beta-HCG test in females of childbearing potential within 3 weeks of enrollment * Subjects of childbearing or child fathering potential must be willing to practice birth control from the time of enrollment on this study Page 10 of 83 Version 1.0 dated 27-April-2023 and for six (6) months after receiving the preparative conditioning regimen. * Must be able to give informed consent. Legal authorized representative (LAR) is permitted if subject is cognitively able to provide verbal assent. Exclusion Criteria: * History of dasatinib intolerance * Known sensitivity or allergy to aminoglycosides or any agents/reagents used in this study * Blast count \> 75% in the bone marrow. * History of malignancy other than non-melanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 2 years * Presence of CNS-3 disease with neurological changes * History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage with clinical signs or symptoms * History of concomitant genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman-Diamond or any known bone marrow failure syndrome * History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment * Primary immunodeficiency * Known infection with HIV, hepatitis B (HBsAg positive) or untreated hepatitis C virus * Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management. * Salvage chemotherapy including TKIs for Ph+ ALL within 1 week prior to enrollment * Pregnant or breast feeding * Patients with known autoimmune disease requiring the use of systemic immunosuppressive therapy within the last year * Corticosteroid therapy within 7 days prior to enrollment * Acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment * Live vaccine ≤ 4 weeks prior to enrollment * Any medical condition that in the judgement of the investigator is likely to interfere with assessment of safety or efficacy of study treatment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Stanford University
Palo Alto, California, 94305, United States
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